Commissioning Qualification Engineer

Overview

Supports pharma equipment commissioning, qualification, and project delivery across the lifecycle.

Key Responsibilities

• regulatory compliance
• p&id walkdowns
• process engineering
• commissioning
• documentation
• data analysis

Tasks

-Promote cGMP and regulatory compliance into assigned projects -Perform systems and P&ID Walkdowns -Perform several activities on clean water systems, compressed gases systems, CIP, mixing and storage vessels, distribution systems, and other pharmaceutical process equipment. Major activities include the following: -Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment -Document, monitor, and report on project deliverables -Manage project documentation such as protocols, reports, calibration certificates, and process trends and be able to report findings to clients and vendors -Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports -Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget. -Review and modification of standard operating procedures (SOPs) for various equipment -Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs) -Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors

Requirements

• chemical engineering
• safety
• problem solving
• communication
• prioritization
• interpersonal

What You Bring

-Demonstrated ability to manage multiple priorities with aggressive timelines -Willingness to travel within the United States as needed -Ability to relate with people at all levels within an organization, including diverse cultures -BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience -Experience in construction safety and manufacturing safety -Effective written communication utilizing GDP; effective oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately -Ability to create an environment of trust, compliance, continuous improvement and learning -Ability to work on complex or undefined problems and quickly identify and address critical issues

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About Hyde Engineering + Consulting

-Began as a niche engineering consultancy focused on biopharma. -Operates 11 offices across North America, Europe, and Asia. -Primary focus areas include process system design, commissioning & validation, FDA compliance, and cleaning technologies. -Significant projects involve pharmaceutical manufacturing facilities, bioprocess plants, and clean utility systems. -Maintains a global presence while providing local engineering expertise. -Employee-owned through an ESOP since 2017, aligning staff incentives with company performance.

Sector Specialisms